Plexin B2 Gene Expression and Polymorphisms in Psoriasis

Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to NB-UVB, Acitretin and Combined Therapy

Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . investigator will be blinded to study drug assignment , while patients and data interpreter will not be masked to study drug assignment.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Radiation: Narrow band Ultraviolet B phototherapy group; Drug: Acitretin group; Combination product: Acitretin plus Narrow band Ultraviolet B phototherapy group

Detailed Description

Study Setting: Qena University Hospital, Department of Dermatology ,Venereology& Andrology.

Study subjects: the study will include psoriasis Vulgaris patients who Come to the out patients dermatologic clinic and matching inclusion & exclusion criteria as follow, from 9/2021 up to 3/2023 and then patients will be divided to each group equally as follow:

Group 1: Patients will be treated with NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.

Group 2: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months Group 3: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Group 4: 30 healthy individuals un related , age, sex , BMI matched with volunteers.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Qina, Egypt
    • Faculty of Medicine , South Valley University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris.
• patients able to swallow tablet and receive Narrow band Ultraviolet B phototherapy without any contraindication

Exclusion Criteria:

Pregnancy , lactation & women intent to become pregnant within 3 year after discontinuation of acitretin Patients with Hyperlipidemia Patients with mental problems and depression Patients with a history of malignancies, renal & liver diseases. Patients with a history of any inflammatory diseases as atopic dermatitis , asthma ulcerative colitis ) and Crohn's disease Patients received NB-UVB phototherapy in the last 6 months. Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Narrow band Ultraviolet B phototherapy group; Patients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.	Radiation: Narrow band Ultraviolet B phototherapy group; 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.; Other Names: NB-UVB
Active Comparator: Acitretin group; Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months	Drug: Acitretin group; dose of 0.5-1 mg per kg per day orally for 3 month.
Active Comparator: Acitretin plus Narrow band Ultraviolet B phototherapy group; Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.	Combination product: Acitretin plus Narrow band Ultraviolet B phototherapy group; Acitretin in dose of 0.5-1 mg per kg per day orally plus Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
No Intervention: Control group; 30 healthy individuals un related , age, sex , BMI matched with volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve the prognosis of patients with psoriasis Vulgaris	detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on genetic mutation and level of plexin b2 in patients with psoriasis Vulgaris	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve the clinical out comes of patients with psoriasis Vulgaris	detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on clinical out comes and PASI score of patients with psoriasis Vulgaris	12 month

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Study Chair: Eisa Hegazy, Prof., Faculty of Medicine, South Valley University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Keratolytic Agents; Acitretin
• Other Study ID Numbers: Ebtehal Mohamed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No